PBS listing delivers first IL-4/IL-13 inhibitor for young children with severe asthma

From 1 September, children aged 6–11 years with severe and uncontrolled asthma driven by type 2 inflammation will have access to Sanofi’s biologic therapy Dupixent (dupilumab) through the Pharmaceutical Benefits Scheme (PBS). Dupixent is the first medicine that inhibits the proteins IL-4 and IL-13, known triggers of airway inflammation.

Professor Connie Katelaris AM, Consultant Physician in Immunology & Allergy, said “Living with severe asthma can be enormously debilitating for children and their parents. For many families, it involves a revolving door of hospitalisations despite their best efforts to avoid triggers and have control of asthma symptoms.

“A new treatment option that targets the underlying inflammation will change the way severe childhood asthma is managed in Australia. While traditional asthma medicines work for thousands of children, hundreds remain at high risk of repeated trips to hospital. These are the children most likely to be eligible for access to Dupixent through the PBS.”

Each year, around 13,500 Australian children are hospitalised for asthma, accounting for 43% of all asthma-related hospital admissions nationwide.

Kate Miranda, CEO of Asthma Australia, welcomed the PBS listing, saying “We know that children with severe asthma experience frequent hospital visits, ongoing symptoms and serious disruption to their daily lives.

“Asthma Australia welcomes the listing of Dupixent on the PBS for children aged 6–11 with severe asthma. This provides a much-needed, affordable treatment option for many children whose asthma remains uncontrolled despite best efforts.”

The data from the Voyage phase 3 trial established Dupixent as the first monoclonal antibody plus standard-of-care therapy to deliver significant and durable improvements in lung function for children aged 6–11 with moderate-to-severe asthma. The IL-4/IL-13 suppression appears to be the only mechanism that leads to sustained improvements in lung function for paediatric patients with asthma.

James Scott, Medical Head, Pharma, Sanofi Australia and New Zealand, said the PBS listing represents a landmark step.

“While Dupixent is widely used to treat severe forms of asthma and atopic dermatitis in adolescents and adults, this is the first time the therapy has been subsidised by the Federal Government for children with severe asthma,” commented Scott.

Dupixent can now be administered via a pre-filled pen, allowing parents to treat their child at home instead of visiting a treatment centre every two weeks.

“This is an important milestone for those children, and their families, who have been unable to control asthma with existing therapies,” added Scott.

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